Prognostic Test For Assessment Of Chronic Kidney Disease Progression
Clinical Chemistry · 21 CFR 862.1223
A prognostic test for assessment of chronic kidney disease progression is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples as an aid in assessing the risk for progression of chronic kidney disease. This device is not intended for diagnosis of any disease, for serial monitoring of kidney disease progression, or for monitoring the effect of any therapeutic product.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
3 recall events for this product code
- GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Kidney Test
Distribution without premarket approval/clearance.
Z-0800-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Liver Test
Distribution without premarket approval/clearance.
Z-0801-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Allergy & Food Intolerance Test
Distribution without premarket approval/clearance.
Z-0802-2026 · View FDA record ↗
Registered firms
1 firms currently registered for this product code
510(k) clearances
1 clearances for this product code